FROM INTERVENTION DEVELOPMENT TO SERVICES: EXPLORATORY RESEARCH GRANTS (R34) RELEASE DATE: March 18, 2003 PA NUMBER: PAR-03-078 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date. The non-AIDS portion of this funding opportunity expires on the date indicated below. A Replacement R34 (PAR-06-248) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for AIDS and AIDS-Related Applications: May 2, 2006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA) replaces the following R21 Announcements: Exploratory/Development Grants for Mental Health Intervention Research (PA-99-134), Pilot Effectiveness Trials for Mental Disorders (PAR-99-118), and NIMH Therapeutic Effectiveness Protocol Development Program (PAR-99-119). The purpose of this R34 is to encourage research on 1) the development and/or pilot testing of new or adapted interventions 2) pilot testing interventions with demonstrated efficacy in broader scale effectiveness trials, or 3) innovative services research directions that require preliminary testing or development. This mechanism provides resources for evaluating the feasibility, tolerability, acceptability and safety of novel approaches to improving mental health and modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention or services study. NIMH intervention and services research is aimed at preventing or ameliorating mental disorders, emotional or behavioral problems, the co-occurrence of mental, physical and substance abuse problems, HIV infections, and the functional consequences of these problems across the life span. This PA addresses several recommendations of the National Advisory Mental Health Council: Bridging Science and Service (http://www.nimh.nih.gov/research/bridge.htm); Translating Behavioral Science into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm); and Priorities for Prevention Research at NIMH (http://www.nimh.nih.gov/research/priorrpt/index.htm). RESEARCH OBJECTIVES Exploratory Development grants for MH Intervention and Services Research are designed to support the early phases of intervention development or adaptation, protocol development and preliminary pilot testing to support a full-scale (e.g., RO1) efficacy or effectiveness study, and innovative services research. For the purpose of intervention development or pilot testing, "intervention" is broadly defined to include psychosocial, pharmacologic, somatic or combination approaches to prevent disorder; efforts to treat disorder in the acute and later phases, such as continuation and maintenance; efforts to prevent relapse, side effects, or co-morbid symptoms and disorders; rehabilitative efforts to reduce residual symptoms and/or enhance functioning; efforts to target provider behavior change; or system organizational efforts to improve care quality, coordination or delivery. In terms of innovative services research, pilot studies might include explorations of the use of approaches and concepts new to a particular substantive area, research and development of new techniques, or initial research to develop a body of data upon which significant future research may be built (i.e., potential for high impact). Integrated preventive, rehabilitative, treatment and services strategies should consider the timing and sequencing of these strategies, as well as the development of incremental outcome measures that could reflect cumulative effects of multiple interventions. Outcomes may be defined at the individual, group, system, or population levels, or any of these in combination. 1. Development and Pilot Testing of New or Adapted Interventions Intervention development can be considered to have three stages: 1) conceptualizing an intervention based on theory and empirical research, 2) developing and standardizing the intervention, and 3) pilot testing. (Stage 1) Applicants should explicate a clear conceptual link between relevant psychological or behavioral factors, various intervention components being proposed (including a description of the mechanisms of action by which these components are hypothesized to have an effect), and their relationship to the particular aspects of outcome that are being targeted. It is also appropriate to present data from prior research describing characteristics of client subgroups, settings, care providers or other relevant variables that were associated with non-response, partial response or relapse. New interventions should be designed or adapted to address factors (such as participant personality variables, expectancies or preferences, behavioral and interpersonal skills deficits, training/supervision of care providers, organizational characteristics, insufficient medication dosing, etc.) that have previously been identified as predictors of positive or negative client outcomes. High priority will be given to applications that demonstrate the systematic translation of basic behavioral and neurobiological processes (e.g., cognition, memory, attention, emotion, personality) into applied interventions. Attention should also be given to the effects of these interventions with underserved populations in disparate social, economic, cultural and environmental contexts. (Stage 2) Standardization of an intervention includes procedures such as the following: development of a treatment protocol (e.g., psychotherapy manual, medication dosing schedule, quality improvement effort) including iterations to this protocol based on information such as feedback from patients, care providers and other investigators; development or adaptation of relevant measures including diagnostic, cost and outcome assessments; formulation of measures of provider competency, acceptance and adherence to the protocol, implementation fidelity, and participant acceptance and/or behavior change related to the treatment. Components of the intervention should be operationalized in as much detail as appropriate commensurate with its present stage of development. (Stage 3) Pilot and feasibility studies involve testing and further refining the intervention manual and measures developed during Stage 2. Typically, data are gathered to estimate intervention parameters (e.g., effect size, attrition rates, response rates) and to perform preliminary power analyses. In some instances pilot tests take the form of small, tightly controlled efficacy trials designed to hold constant or eliminate any factors that could reduce the treatment effect, including patient heterogeneity. However, under other circumstances an alternative design might be more appropriate depending upon the nature of the research question, the number of participants included in the study, the characteristics of the disorder or population being studied, the risks and benefits of providing (or withholding) an intervention from the target population, subject recruitment concerns (especially for rare diseases), or the availability of other effective interventions to patients in their communities. Therefore, under certain circumstances, investigators might need to consider alternative methodologies, including quasi-experimental or even uncontrolled single case designs, if necessary. It is the responsibility of the investigator to provide a justification for the type of experimental design chosen. In summary, the goal of this phase of research is for the investigator to propose the most rigorous means of collecting data (in light of ethical or other limitations) that will prepare him or her to conduct a larger, more definitive test of the intervention in the future. For exploratory/development grants, the goals of the study should be clearly outlined and related to specific aims and procedures pertinent to whichever stage(s)of development will be pursued. It is acknowledged that boundaries between the stages above are non-discrete and therefore, investigators may propose ideas or methods including subsets of one or more categories. Importantly, however, the proposal should include a clearly operationalized description of each component step, with decision points indicating when each has been successfully completed and when to move onto subsequent components. Furthermore, investigators are not expected to necessarily complete all phases of development during the 3-year duration of the award. They should propose feasible and systematic goals that can be accomplished within the time and funding constraints of this award while considering the aim of accomplishing the prerequisites for conducting a larger (e.g., R01) study. Examples of possible intervention development or adaptation studies include, but are not limited to: o Development of novel interventions to target specific risk factors for psychopathology, co-morbid mental and other physical disorders, vulnerability to HIV infection, or etiologic factors identified through basic behavioral, epidemiological or neuroscience research o Adaptation of specific interventions already established as efficacious in one target population or domain to be applied to a different group (e.g., diverse cultural groups, children, older adults) or target behavior (e.g., adherence, HIV-risk reduction). o Development and/or standardization of naturally occurring helping resources in the community or nontraditional forms of intervention delivery. 2. Adaptation and Pilot Testing for Effectiveness The principal aim of effectiveness (or public health-oriented) research is to determine whether interventions with demonstrated efficacy under tightly controlled conditions can have a measurable beneficial effect when implemented in less precisely controlled circumstances with more heterogeneous populations, providers and settings. These studies have broad inclusion and relatively few exclusion criteria. Exclusion criteria are based more on concerns for participants' safety than on achieving tight control over extraneous sources of variation that may complicate causal interpretations of intervention effects. Age, gender, ethnic minority status, and comorbidity are seen as important dimensions on which to ensure sample representativeness and generalizability, rather than as bases for participant exclusion. Potential outcomes are broad and often include variables such as performance (school, work, etc.), relationship functioning (family, interpersonal, etc.), HIV risk reduction, disability, quality of life, mortality, institutionalization, and health care resource use in addition to measures of psychiatric morbidity. When conducting effectiveness research on an intervention with previously demonstrated efficacy, information regarding its initial degree of "fit" within an applied setting (e.g., specialty or primary care, school or work site) and the iterative process that is expected to occur when altering the intervention for successful implementation within this setting should be articulated. Examples of possible research questions include, but are not limited to: o Studies to broaden understanding of an existing preventive or treatment intervention strategy (e.g., dosage, duration, care delivery system fit, prevention setting) o Feasibility studies to gather estimates of parameters necessary for the conduct of larger scale effectiveness trials (e.g., effect sizes, population variance) o Standardization of research instruments, database construction and protocol development for conducting full-scale effectiveness studies o Studies to develop and standardize provider training protocols, supervisory standards, or implementation of fidelity procedures 3. Innovative Services Research This program announcement is also intended to encourage applications to facilitate innovative services research directions that require preliminary testing or development. Such pilot studies might include service delivery model development, explorations of the use of approaches and concepts new to a particular substantive area, research and development of new techniques, or initial research to develop a body of data upon which significant future research may be built (i.e., potential for high impact). Studies designed to develop and/or test novel service delivery models should reflect one or more of the 3 stages of intervention development described in the "Development and Pilot Testing of New or Adapted Interventions" section of this Program Announcement. Additional examples of relevant services research areas might include "practice research," studies of dissemination/implementation and/or organizational processes, and/or the analysis of complex, multi-dimensional mental health care delivery systems. Research in these areas may require novel or mixed methodologies and/or innovative statistical approaches. Consequently, examples of research applications in this area include but are not limited to: o Studies to develop novel service delivery models (e.g., aftercare services, rehabilitation, social setting, school or community-based, online/virtual communities) designed to target children, adolescents, adult or geriatric individuals with complex, comorbid and/or chronic conditions o Studies to develop organizational or systemic interventions to ease administrative burdens, reduce provider turnover or burnout, increase consumer satisfaction or service engagement o Pilot studies to understand "real world" care delivery system characteristics that might facilitate or impede the integration of novel or adapted intervention techniques (e.g., reimbursing physicians for HIV risk reduction counseling during routine visits). o Preliminary studies of new methodological approaches for the analysis of complex and dynamic systems o Studies to design or validate instruments to measure dissemination or implementation processes, changes in consumer functioning, or organizational environments MECHANISM(S) OF SUPPORT This PA will use the NIH R34 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Under this program announcement, applicants for the R34 award may request direct costs of up to $450,000 for three years. For those applications that include a subcontractual/consortium arrangement, facilities and administrative (F&A) costs on those consortium arrangements would be included in the direct costs. While variations from year to year are permissible, in no case may any year be more than 225,000 in direct costs, and total direct costs for the entire project period may not exceed $450,000. Grant applications may request 1, 2, or three years of support. This award is non-renewable. However, it is intended that grantees funded through this exploratory phase program will elect to seek continuing support for their projects through the R01 grant mechanism. This PA uses just-in-time concepts. It also uses modular budgeting format. Given that these applications will have direct costs in each year of $250,000 or less, the modular budgeting format should be used in all applications. (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Any research project which involves a Phase I or Phase II Clinical Trial must include a Data and Safety Monitoring Plan. See the Federal Citations section, below, for further information and references. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Linda Street, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-0651 FAX: (301) 594-6784 Email: Lstreet@nih.gov Dianne Rausch, Ph.D. Deputy Director, Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6212 Rockville, MD 20852 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: dr89b@nih.gov Regina T. Dolan-Sewell, Ph.D. Division of Mental Disorders, Behavioral Research & Aids National Institute of Mental Health 6001 Executive Boulevard, Room 6183, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: rdolan@mail.nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Rockville, MD 20852-9608 (for express/courier service) Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: kozakm@mail.nih.gov o Direct your questions about financial or grants management matters to: Joy R. Knipple Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jk173@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Mental Health Council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o In line with a major purpose of this PA, namely to evaluate the feasibility, tolerability, acceptability and safety of novel approaches to improving mental health, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention or services study: How likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant or full scale clinical trial? Is information provided about the scope and goals of intended future work? o For applications intending to develop or adapt a new treatment or service for a new population, setting or system, is there a clear conceptual link between the nature of the psychopathology, the treatment components proposed, and their relationship to the outcome variables being targeted? Is empirical evidence available which demonstrates the need to adapt an existing intervention or service e.g., because in its current form it has failed to achieve a complete and lasting remission among all patients in all settings that have received it? Does the application describe how the new adaptation will enhance responding for subgroups of patients that previously experienced partial remission, relapse or dropped out from the existing therapy? o For applications intending to develop or adapt a new treatment or service, is there an adequate description of which stage of intervention development best characterizes the application and is a clear rationale provided for the choice of methods proposed? For stage 3 applications, investigators are not limited to use of between group designs for pilot studies. In the absence of a controlled design, do such applications describe the use of other, innovative (e.g., single case, quasi experimental or uncontrolled) designs that best take into account the ethical and methodological considerations that arise when using small sample sizes (e.g., the statistical concerns that arise when comparing 2 active treatments, the risks of withholding treatment from seriously ill patients, the availability of alternative effective treatments in the community, etc.)? Does the application adequately consider these issues in choosing the most appropriate research design and providing a clear explanation for their decision? Whenever possible, are mechanisms of action, that are hypothesized to have an effect on patient outcome, articulated? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines _amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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